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Medical devices demand an exceptionally high level of precision, safety, and regulatory compliance. The stakes in healthcare are uniquely high: device failures can jeopardise patient health, trigger costly recalls, and erode brand trust.
As your reliable Electronics Manufacturing Services (EMS) partner, we ensure consistent, high-quality production, supports compliance with standards such as ISO 13485, enables faster time-to-market and scalable manufacturing, and contributes to efficient distribution, near and far.
At J-TEQ, we specialise in core manufacturing process technologies that serve the medical device industry, including:
ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
In the highly regulated medical device manufacturing industry, ISO 13485 is a must, not an option. As an ISO 13458-certified EMS provider, J-TEQ is deeply committed to quality, safety, and regulatory alignment. As your trusted partner, this means fewer production delays, recalls, and compliance headaches.
ISO 13485 is aligned with FDA 21 CFR Part 820 (U.S.), EU MDR, Health Canada, TGA (Australia), and other regulatory systems, making us an ideal partner for OEMs targeting multi-region distribution with fewer regulatory roadblocks.
With decades of industry experience, J-TEQ is your trusted partner in medical device development and manufacturing. Our robust yet flexible manufacturing and assembly capabilities have in fact made us a preferred partner for some of the most innovative companies in healthcare technology.
A leading provider of wearable health monitoring devices and remote patient care solutions relies on our expertise in PCBA to manufacture critical components of their health monitoring systems.
These devices are essential for real-time patient health tracking, particularly in remote patient monitoring solutions that have seen rapid growth in recent years.
As a global leader in diagnostic imaging partners with J-TEQ for the production of highly precise PCBA and integrated assemblies for their medical imaging systems.
Our manufacturing services are integral to the performance of their ultrasound and MRI devices, where accuracy and dependability are paramount.
A specialist in innovative patient monitoring technologies depends on J-TEQ's full turnkey solutions to produce patient monitoring devices that meet the highest industry standards.
We ensure that their products are ready for market with fully integrated systems and quality-checked components.
A pioneering company in microwave healthcare technology partners with us to produce sophisticated medical devices designed for non-invasive treatments.
Our turnkey manufacturing solutions, from PCBA to final box build, play a critical role in bringing their innovative healthcare technologies to market.
Our industry experience and proven track record of success in medical device manufacturing serve as a testament to our ability to deliver compliant, reliable, and high-performance solutions as well as our dedication to improving lives through every product we help bring to market.
Partner with us and gain a trusted manufacturing ally who understands the critical nature of your work.
